Most patients will derive no health improvement from medication. We should tackle the root causes of disease instead

When former airline pilot Tony Royle came to see me last year to seek reassurance that it was OK to participate in an Ironman event, having stopped all his medications 18 months after suffering a heart attack, I was initially a little alarmed.

But after talking to him, I realised he had made an informed decision to stop the medication after suffering side effects, and instead had opted for a diet and lifestyle approach to manage his heart disease.

His case is a great example of how evidence-based medicine should be practised. This is the integration of clinical expertise, the best available evidence and – most importantly – taking patients’ preferences and values into consideration.

At a time when drug company lobbyists are widely vilified as icons of avarice, patient advocacy groups still wear the white hats.

But those organizations, which promote cures for every type of cancer and hundreds more diseases, have come under criticism lately for favoring their drug company funders in contests on Capitol Hill.

In one case, a diabetes group accepted money from food companies and played down the health risks from their high-sugar products; in another case, a mental health association, reliant on drug company dollars, opted to keep quiet about the soaring prices of its antidepressants. And many of the patient advocacy groups pushing for passage of the 21st Century Cures Act, which consumer groups argue rolls back patient protection, are funded in large part by pharmaceutical firms.

Most patient and consumer advocacy groups receive funds from the pharmaceutical industry, according to a new study released by the group PharmedOut.

Only a handful out of 7,685 health advocacy groups in the U.S. are completely independent of pharmaceutical industry money, according to a list the group released Oct. 13. PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates health-care professionals about pharmaceutical marketing practices.

And industry funding of patient groups, including websites and informational materials, is often not apparent to the average consumer, which could mislead consumers into believing they’re getting unbiased health advice.

“Industry funding is often not disclosed on websites or informational materials or is hidden,” PharmedOut Director Adriane Fugh-Berman told me in an Oct. 16 phone call. Funding and sponsorship is often very subtle and difficult to identify, she said.

In addition, she said, industry sponsorship can affect the stands patient and consumer groups are willing to take, she said.

Groups that accept industry funding are affected by that money, regardless of whether they think they are, she said.

"Look at the stands taken and not taken,” she said. “For example, where is the anger and outrage about drug costs?”

Fugh-Berman is an associate professor in the Department of Pharmacology and Physiology and in the Department of Family Medicine at Georgetown University Medical Center.

Pharmaceutical companies can use social media to engage and educate patients as well as to provide reliable information about their products. But how do companies tap social media without running afoul of the Food and Drug Administration (FDA) and various regulatory requirements? To find out, I asked Colleen Tracy James, a partner in Mayer Brown’s New York office, where she is a member of the firm’s intellectual property practice and life sciences group.

Belbey: What are the challenges facing pharmaceutical firms when using social media?

James: The internet is the wild wild West. We are still figuring out how to maneuver and make sure information is reliable and trustworthy. This is especially important when it comes to pharmaceutical products because it impacts our health and well-being. Pharmaceutical companies face a lot of challenges on social media, such as how to handle incomplete and misinformation about their products. We all remember the famous Kim Kardashian Instagram post where she touted the benefit of a drug that treats morning sickness, but she did not disclose any of the side effects. According to the FDA Guidance, when you use social media, you need to include the ‘good, bad and the ugly' about your product. Your social media posts need to be fair and balanced.

Belbey: How can pharmaceutical companies control the message and the information?

James: One way to control the message is to create what the industry calls a “controlled environment” such as creating a company webpage for a drug or disease. In this way, firms can make sure information is accurate and complete. That keeps them in line with the FDA regulations. That’s very different from third party information, where the company does not have control over how its product are discussed.

Belbey: Can firms use controlled environments and social media to correct misinformation?

James: Yes. If patients are talking to each other and sharing a misconception of your product, you may want to, as a company, respond to that. You may decide to allow certain employees in the corporation to engage with potential consumers on social media and to answer questions. Or you could provide a chat room as part of your own platform. In that case, your obligation to correct misinformation may be heightened because now you have control of that website.

Belbey: How can pharmaceutical firms use Twitter?

James: Twitter is one of the areas where we’ve seen some specific guidance from the FDA. Due to its character limitations, the FDA is concerned that if you don’t have enough space, you can’t provide a fair and balanced (benefits and downsides) view of your drug. Pharmaceutical companies face serious penalties by the FDA if they don’t make the proper disclosures -- something that pharmaceutical companies want to avoid. If you are responsible for disseminating misinformation about your drug, and the wrong person takes it because he or she wasn’t aware of the contraindications or the side effects, the pharmaceutical companies open themselves up for liability. In short, pharmaceutical companies must be careful not to mislead consumers on Twitter.

Belbey: Given that there are real risks associated with not complying with advertising rules and regulations, how should firms move forward safely?

James: Pharmaceutical firms should develop clear and decisive social media advertising policies. First, they need to figure out which platforms they will use, how they will control their messages, whether they’re going to allow chat rooms, and how to manage comments from patients who want a dialog. If interactivity is permitted, companies need to clearly define which employees may interact with consumers, patients and doctors on social media.

The firm also needs a content strategy, so that responses are in compliance with what the FDA has approved the pharmaceutical company may say about their product. You also may need a team of legal advisers to confirm that content about your product is okay to put on social media. Pharmaceutical companies must be careful that employees don’t provide people with wrong information when responding on social media. For example, you can’t say, “This medication is for a headache but you can also take it for something else that’s not a headache.” That would be a violation, historically speaking, as firms are not allowed to market their drugs’ off-label uses or mention off-label uses. And finally, I also suggest that companies have a compliance officer tasked with making sure there’s a policy in place and it’s being complied with and updated with evolving FDA guidance.

Since the FDA was created, we’ve gone from radio to TV and to now social media. Just like the past when industry adapted to new forms of communications, pharmaceutical companies are now figuring out how to advertise and communicate using the latest media within the regulatory framework.

It’s patients who lose out if doctors and professional journals stop asking the right questions.

During a recent clinic consultation, I saw Mary, in her early 60s, with type 2 diabetes. She was concerned that the muscle pains in her legs may have been a result of the cholesterol-lowering statin drug she was taking. “But I’m scared of stopping it.” She explained how a specialist nurse had told her a clot could break off from her aorta, travel to her brain and cause a massive stroke.

I assured her that even in those with established heart disease, who stand to gain most from taking the drug, the risk of death from stopping the medication for two weeks to see if the side-effects would go was close to 1 in 10,000 .

Unfortunately, such misinformation and fear-mongering is common. One of the root causes is undoubtedly driven by the commercial interests of the pharmaceutical industry.

As cardiologist eter Wilmshurst points out in a talk he gave at the Centre for Evidence-Based Medicine last year, the drug and device industry has an ethical and legal responsibility to produce profit for their shareholders but not to sell patients and doctors the best treatment. But the real scandal, he says, is the failure of regulators and the collusion of sorts between doctors, institutions and medical journals.

Amazon’s web services are now worth more than its entire retail operation – and growing three times as fast.

The internet, in just two decades, has gone from something that seemed exotic to most people to a utility that is taken for granted – like electricity. Just as most people – at least in industrial societies – rarely go through a day without switching on a light, so most of us use the internet every day. In that sense, it has become what historians of technology call a GPT – a general purpose technology, like steam power, electricity, mass production and the automobile.

In 1999, Andy Grove, then the CEO of Intel, was widely ridiculed for declaringthat “in five years’ time there won’t be any internet companies. All companies will be internet companies or they will be dead.” What he meant was that anybody who aspired to be in business in 2004 would have to deal with the internet in one way or another, just as they relied on electricity. And he was right; that’s what a GPT is like: it’s pervasive.

Could our relentless pursuit of good health be making us sick? Advances in medicine have propelled health care to new heights and a vast array of diagnostic tests and drug therapies is now available. But are we getting too much of a good thing? An increasing number of doctors now say that sometimes, "less is more" when it comes to medical interventions. Some doctors are concerned that resources are being wasted on the "worried well" and that the ever-expanding definition of how we define "disease" has been influenced by vested interests. Could excessive medical interventions be causing more harm than good? Dr Maryanne Demasi examines how our relentless pursuit for good health might be making us sick

Are you overpaying for your health care compared with those in a nearby city? The arbitrary pricing strategies put in place by health care providers makes large pricing swings the rule rather than the exception, experts say. It’s a puzzling (and little-known) fact of the health care industry: Health

Issues

Alcohol companies have recently invested large sums of money in answering research questions to which they have clear vested interests in the outcomes. There have been extensive concerns about corporate influence on public health sciences, following the experience with the tobacco industry.

Approach

This systematic review aims to investigate the perspectives of researchers on the activities of alcohol industry actors in relation to science, in order to guide future research. All data published in peer‐reviewed journals (including commentaries, opinion pieces, editorials and letters as well as research reports) were eligible for inclusion. This analysis focuses on the manifest rather than latent content of the articulated views, and accordingly adopts a thematic analysis using an inductive approach to the generation of themes.

Key Findings

There are serious concerns identified in three main areas, principally defined by where the impacts of industry scientific activities occur; on evidence informed policy making (instrumental uses of research by industry actors), on the content of the scientific evidence base itself (industry funding as a source of bias); and on the processes of undertaking research (transgressions of basic scientific norms). There are also opposing views which provide a useful critique. The evidence‐base on the validity of all concerns has been slow to develop.

Systematic review highlights significant concerns about alcohol industry influence on how research is conducted, study findings and how they are translated into policy. It also notes the lack of research into this issue.

“Patient advocacy” groups have a unique power on Capitol Hill. They claim to represent the true voice of constituents, untainted by special interest bias. Politicians and the Food and Drug Administration use their endorsements as reflective of genuine public support.

But a new study shows that nearly all of these patient advocacy groups are captured by the drug industry.

David Hilzenrath at the Project on Government Oversight (POGO) reports that at least 39 of 42 patient advocacy groups who participated in discussions with the FDA over agency review processes for prescription drugs received funding from pharmaceutical companies. And at least 15 have representatives of drug or biotechnology companies on their governing boards.

The study is particularly notable now because Congress is poised to pass the 21st Century Cures Act, which trades temporary additional funding for the National Institutes of Health and the FDA for permanent weakening of the FDA’s approval process. Over 1,400 lobbyists have been working on this bill, which would be a major financial boon to the drug and medical device industries.

Patient advocacy groups have factored heavily into the lobbying effort. According to an analysis from research group Avalere in December 2014, 43 percent of public comments on the House version of the bill were from patient advocacy groups.

But those groups are not necessarily independent, POGO warns.

For instance, the National Health Council, a group that calls itself “The United Patient Voice” and has advocated before the FDA for faster drug approvals, includes on its board of directors leaders of the two main trade groups for the drug industry — Pharmaceutical Research and Manufacturers of America (PhRMA), and Biotechnology Innovation Organization (BIO) – along with executives from drug companies Sanofi, Johnson & Johnson, and Alkermes. PhRMA gave the National Health Council $1.2 million in 2014; in all, 77 percent of its funding came from the pharmaceutical and biotech industries, according to POGO. Its “Policy Action Team” also has a PhMRA representative on it, along with an employee of Johnson & Johnson.

This is a list of health advocacy and consumer groups in the U.S. and Canada that take no funding from pharmaceutical, medical device, or biotech companies. The voices of independent groups that truly represent patients and consumers are drowned out by the thousands of groups that take money from industry and push industry viewpoints – or stay silent on drug safety, drug costs, and other issues vital to patients. This list is meant to be a resource for media and consumers who want to listen to – and support – independent groups whose opinions are not swayed by industry.

To learn more about pharma-funded advocacy groups, please read some of our articles on how pharma-funded groups negatively affect healthcare. For an in-depth analysis of the effect of industry funding of breast cancer groups, check out Health Advocacy, Inc.

Want to be on the list? If you represent a patient or consumer health advocacy group that does not take money from manufacturers of drugs, medical devices, biologics, or diagnostics, please email us at pharmedout@gmail.com with a link to your organization's website, 3 years worth of 990s (or t1004 or t3020 for Canadian groups) and annual reports, and a statement that the organization does not take money from industry and has a policy not to take money from industry. The groups submitted will be vetted by a committee that includes Sharon Batt PhD, author of Health Advocacy, Inc. and Adriane Fugh-Berman MD, director of PharmedOut.

Can Pharmaceuticals Buy Doctor's Prescription Pads? Its a complicated topic but new evidence suggests it might be harder than reported in the past. Using prostate cancer drugs these investigators did not find pharmaceutical payments impact doctor's habits at all.

The short answer is we found very little correlation between payments given to physicians and the amount of drug they dispense. In fact, the median amount of prescribed drugs was exactly the same between those doctors who received money from the pharmaceutical companies and those that did not. You can read the paper to get a feel for some of the other nuances of our findings but suffice it to say no strong relationship was seen. Within this narrow spectrum of prostate cancer drugs, pharma payments did not seem to make a difference at all to the prescribing habits of doctors.

Facing state budget cuts to the University of Wisconsin system and dwindling federal funding, Robert Golden would love to find a pile of money somewhere.

But there are certain things Golden — and some other medical school officials across the country — say they won't do: take money from drug companies for doctor education programs and let them have any say in what goes into the courses.

Would you accept money "with no strings attached" from a robber who, in the act of stealing, happened to kill some of his victims? Would you accept money that has been stolen? Would you accept sponsorships from tobacco companies for a meeting about lung diseases? Few doctors would. Why is it then that most doctors willingly accept sponsorships from drug companies that have earned much of their money illegally while being fully aware that their criminal activities have killed thousands of patients, the very people whose interests doctors are supposed to take care of?

To identify the impact of industry involvement in the publication and interpretation of meta-analyses of antidepressant trials in depression.

Study Design and Setting

Using MEDLINE, we identified all meta-analyses evaluating antidepressants for depression published in January 2007–March 2014. We extracted data pertaining to author affiliations, conflicts of interest, and whether the conclusion of the abstract included negative statements on whether the antidepressant(s) were effective or safe.

Results

We identified 185 eligible meta-analyses. Fifty-four meta-analyses (29%) had authors who were employees of the assessed drug manufacturer, and 147 (79%) had some industry link (sponsorship or authors who were industry employees and/or had conflicts of interest). Only 58 meta-analyses (31%) had negative statements in the concluding statement of the abstract. Meta-analyses including an author who were employees of the manufacturer of the assessed drug were 22-fold less likely to have negative statements about the drug than other meta-analyses [1/54 (2%) vs. 57/131 (44%); P < 0.001].

Conclusion

There is a massive production of meta-analyses of antidepressants for depression authored by or linked to the industry, and they almost never report any caveats about antidepressants in their abstracts. Our findings add a note of caution for meta-analyses with ties to the manufacturers of the assessed products.

What is overuse?Overuse is a catchall term for medical tests, treatments, and other services that patients don’t need or don’t want.

Overuse occurs when a patient is hospitalized unnecessarily, or receives a test, treatment, drug, or procedure that is unnecessary, ineffective, or unwanted.

“Unnecessary” means that a particular patient is very unlikely to benefit from the treatment because they don’t have the disease or symptom it’s intended to diagnose or treat, or because the possible harms of treatment outweigh the possible benefits.

“Ineffective” means that the treatment has been shown to be no more effective than no treatment or a placebo (sugar pill or sham surgery).

“Unwanted” means that the patient, if fully informed, would choose another testing or treatment option.

Estimates of the money wasted on overuse each year range from around $200 billion to over$800 billion – between 10 percent and 30 percent of US health care spending.

Overdiagnosis is a related problem, where patients are diagnosed with conditions that were unlikely to cause symptoms or shorten the patient’s life. With increased use of screening tests and highly sensitive imaging technologies such as MRI and CT scans, more conditions are being diagnosed based on anatomical abnormalities and treated as actual disease. This is most common for cancers like breast, prostate, and thyroid cancer, many cases of which are slow-growing and not harmful, but which many patients and doctors are uncomfortable leaving untreated. Overdiagnosis is also common for some mental health conditions, such as ADHD in children.

A review of studies that assess clinical antidepressants shows hidden conflicts of interest and financial ties to corporate drugmakers.

After many lawsuits and a 2012 U.S. Department of Justice settlement, last month an independent review found that antidepressant drug Paxil (paroxetine) is not safe for teenagers. The finding contradicts the conclusions of the initial 2001 drug trial, which the manufacturer GlaxoSmithKline had funded, then used its results to market Paxil as safe for adolescents.

The original trial, known as Study 329, is but one high-profile example of pharmaceutical industry influence known to pervade scientific research, including clinical trials the U.S. Food and Drug Administration requires pharma companies to fund in order to assess their products. For that reason, people who read scientific papers as part of their jobs have come to rely on meta-analyses, supposedly thorough reviews summarizing the evidence from multiple trials, rather than trust individual studies. But a new analysis casts doubt on that practice as well, finding that the vast majority of meta-analyses of antidepressants have some industry link, with a corresponding suppression of negative results.

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